NCT02949726

Brief Summary

The goal of this study is to find out which immune molecules, cells, and genes are involved in the development of lymphedema (LE), so that medicines that target them can be considered for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly chemotherapy in genetically susceptible patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 24, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

5.4 years

First QC Date

July 11, 2016

Last Update Submit

December 12, 2023

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (25)

  • Lymphatic propulsive velocity as assessed by NIRFLI

    immediately before surgery

  • Lymphatic propulsive velocity as assessed by NIRFLI

    immediately before radiation (which is 6-8 weeks after surgery)

  • Lymphatic propulsive velocity as assessed by NIRFLI

    6 months after radiation

  • Lymphatic propulsive velocity as assessed by NIRFLI

    12 months after radiation

  • Lymphatic propulsive velocity as assessed by NIRFLI

    24 months after radiation

  • Lymphatic propulsive frequency as assessed by NIRFLI

    immediately before surgery

  • Lymphatic propulsive frequency as assessed by NIRFLI

    immediately before radiation (which is 6-8 weeks after surgery)

  • Lymphatic propulsive frequency as assessed by NIRFLI

    6 months after radiation

  • Lymphatic propulsive frequency as assessed by NIRFLI

    12 months after radiation

  • Lymphatic propulsive frequency as assessed by NIRFLI

    24 months after radiation

  • Percent extravascular dye as assessed by NIRFLI

    immediately before surgery

  • Percent extravascular dye as assessed by NIRFLI

    immediately before radiation (which is 6-8 weeks after surgery)

  • Percent extravascular dye as assessed by NIRFLI

    6 months after radiation

  • Percent extravascular dye as assessed by NIRFLI

    12 months after radiation

  • Percent extravascular dye as assessed by NIRFLI

    24 months after radiation

  • Vessel tortuosity as assessed by NIRFLI

    immediately before surgery

  • Vessel tortuosity as assessed by NIRFLI

    immediately before radiation (which is 6-8 weeks after surgery)

  • Vessel tortuosity as assessed by NIRFLI

    6 months after radiation

  • Vessel tortuosity as assessed by NIRFLI

    12 months after radiation

  • Vessel tortuosity as assessed by NIRFLI

    24 months after radiation

  • Vessel dilation ratio as assessed by NIRFLI

    immediately before surgery

  • Vessel dilation ratio as assessed by NIRFLI

    immediately before radiation (which is 6-8 weeks after surgery)

  • Vessel dilation ratio as assessed by NIRFLI

    6 months after radiation

  • Vessel dilation ratio as assessed by NIRFLI

    12 months after radiation

  • Vessel dilation ratio as assessed by NIRFLI

    24 months after radiation

Secondary Outcomes (15)

  • Chemokine levels as assessed by bead assay

    immediately before surgery

  • Chemokine levels as assessed by bead assay

    immediately before radiation (which is 6-8 weeks after surgery)

  • Chemokine levels as assessed by bead assay

    6 months after radiation

  • Chemokine levels as assessed by bead assay

    12 months after radiation

  • Chemokine levels as assessed by bead assay

    24 months after radiation

  • +10 more secondary outcomes

Study Arms (1)

Cancer-treated patients receiving NIRFLI

OTHER

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.

Drug: Indocyanine Green (ICG)Device: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)

Interventions

Indocyanine Green (ICG)DRUG

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.

Cancer-treated patients receiving NIRFLI
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)DEVICE

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.

Cancer-treated patients receiving NIRFLI

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be at least 18 years of age
  • Participants must have been clinically diagnosed with breast cancer and scheduled for axillary lymph node dissection (ALND) and radiation treatment at MD Anderson (receiving chemotherapy, mastectomy or breast-conserving surgery, ALND (\>10 nodes) and radiation treatment for breast cancer, identified by Drs. Mittendorf and Shaitelman of the Nellie B. Connally Breast Cancer Center at MD Anderson)
  • Ambulatory and possessing all four limbs
  • No prior radiation therapy
  • Negative urine pregnancy test within 36 hours prior to study drug administration, if of childbearing potential
  • Females participants must complete the Female Enrollment Form. Childbearing potential participants must agree to use one of the medically accepted forms of contraception for a period of one month after study participation. Female participants who meet the criteria for non-childbearing will still complete the Female Enrollment Form, but are not restricted to the use of contraception following study participation.

You may not qualify if:

  • Participants with a known or suspected allergy to iodine
  • Participants who are breastfeeding, pregnant or trying to become pregnant
  • Severe underlying chronic illness or disease (other than breast cancer)
  • Participants not capable of keeping moderately still for the imaging portion of the study session (\~1 hour for imaging)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Melissa B Aldrich, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 11, 2016

First Posted

October 31, 2016

Study Start

April 24, 2017

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations

US(1)